A Study With Lido-Patch and Placebo Plaster in Patients Suffering From Postherpetic Neuralgia (PHN)

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This study investigated the efficacy of the Lido-Patch (lidocaine 5% medicated plaster) in treatment of pain caused by PHN which is a neuropathic pain syndrome (nerve-related pain conditions) following an acute attack of herpes zoster (shingles).

Condition or disease

Intervention/treatment

Phase

Post Herpetic Neuralgia

Drug: Lidocaine 5% medicated PlasterDrug: Placebo Plaster

Phase 3

Detailed Description:

Participants were treated up to 10 weeks in this study: an 8-week Run-in Phase of open-label treatment with Lido-Patch was followed by a 2-day to 14-day Double-blind Phase with Lido-Patch or Placebo Patch treatment. Only participants responding to open-label treatment with Lido-Patch were included in the Double-blind Phase. In a Follow-up Phase without treatment, the safety of participants was monitored for 1-2 weeks. Alternatively, patch application could be continued for up to 12 months in the clinical study KF10004/02.

All participants applied up to 3 Lido-Patches (lidocaine 5% medicated plaster) per day (depending on the size of PHN area). Patches were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.

Drug: Lidocaine 5% medicated Plaster

Other Names:

Versatis (Trade Mark)

Lidoderm (Trade Mark)

Neurodol Tissugel (Trade Mark)

Experimental: Lido-Patch (Double-blind Phase)

Up to 3 patches (lidocaine 5% medicated plaster) per day (depending on the size of PHN area) were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.

Drug: Lidocaine 5% medicated Plaster

Other Names:

Versatis (Trade Mark)

Lidoderm (Trade Mark)

Neurodol Tissugel (Trade Mark)

Placebo Comparator: Placebo Patch (Double-blind Phase)

Up to 3 placebo plasters per day (depending on the size of PHN area) were applied topically for up to 12 hours per day (patch free interval: at least 12 hours) at the site of skin affected by painful PHN.

Time-to-exit in Double-blind Phase Due to Lack of Efficacy [ Time Frame: From Day 1 until time to exit in Double-blind Phase (maximum Day 14) ]

The time to exit was defined as the number of days after randomization where worsening of the pain relief score by 2 or more categories on a 6-item pain relief scale (verbal rating scale, VRS) on 2 consecutive days in comparison to the average pain relief in Week 8 of the Run-in Phase was reported.

The average pain relief in Week 8 of the enrichment phase was to be stated by the participant at the randomization visit. The VRS comprised the categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, 6 = complete.

Pain intensity was assessed as "pain right now" directly before patch application and before patch removal, and as "24-hour average pain" before patch removal using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).

Pain relief was defined as relief at the time point directly before patch removal in comparison to the time point directly before patch application. Pain relief was assessed using a 6-item relief scale (VRS) with categories 1 = worse, 2 = no pain relief, 3 = slight, 4 = moderate, 5 = a lot, and 6 = complete.

The weekly average of the 24-hour average pain intensity was calculated based on corresponding daily pain intensities over the last week before the respective visit. Pain intensities were assessed using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).

Weekly Average Current Pain Intensity: NRS [ Time Frame: During Run-in Phase (visits after 1 and 4 weeks), after 8 weeks, and after 10 weeks (Double-blind Phase) ]

The weekly average of the current pain ("pain right now") intensities before patch application or before patch removal were calculated based on corresponding daily pain intensities over the last week before the respective visit. Pain intensities were assessed using an 11-point Numeric Rating Scale (NRS from 0 = no pain to 10 = pain as bad as you can imagine).

Weekly least pain intensity was assessed in the last week before the respective visit using an 11-point NRS (from 0 = no pain to 10 = pain as bad as you can imagine).

Other Outcome Measures:

Chronic Pain Sleep Inventory (CPSI) [ Time Frame: From screening at each visit up to the final visit (Week 10) [6 time points in total] ]

The CPSI is a 5-point verbal rating scale (VRS) designed to provide information on the influence of the pain on sleep quality with the items trouble falling asleep, needing sleep medication, and awakened by pain during the night/in the morning (categories of the VRS: never, rarely, sometimes, usually, always); in addition, the overall quality of sleep (categories of the VRS: poor, fair, good, very good, and excellent) was assessed. Participants were asked to complete the CPSI questionnaire at each visit.

Investigators were to describe their global impression of change (CGIC), i.e., the overall impression of the change of the participant's condition by answering the question "Compared to the patient's condition at admission to the project, how much has he/she changed?" The verbal rating scale comprises the categories not assessed [0], very much improved [1], much improved [2], minimally improved [3], no change [4], minimally worse [5], much worse [6], and very much worse [7]. When assessing the overall impression, the investigator was to refer to the Run-in Phase only.

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Layout table for eligibility information

Ages Eligible for Study:

50 Years and older (Adult, Older Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria for the Run-in Phase:

Adult participants, male and female, with a minimum age of 50 years at screening.

Participants who had postherpetic neuralgia (PHN) for at least 3 months after healing of a herpes zoster skin rash.

Pain score of at least 4, based on an 11-point numerical rating scale (NRS) (scale of 0-10), at the screening and enrolment visit. The pain assessment is the participant's recall of the pain intensity since the previous week.

Written informed consent given.

Randomization Criteria:

Participants must be regularly (minimum every second day) using the Lido-Patch for control of pain in the last 4 weeks of the run-in phase. The participant must wait for pain to increase before applying a new patch.

The participants' average daily pain intensity (with patch on) must be 7 or less on an 11-point NRS (scale of 0-10), and must increase during the phases when a patch is not worn, during Week 8 of the Run-in Phase.

Before randomization, the participant must have an average relief with Lido-Patch of "moderate" or better, on a 6-item scale (worse, no pain relief, slight, moderate, a lot, complete) during Week 8 of the Run-in Phase.

Exclusion Criteria:

Participation in another study of investigational drugs or devices parallel to, or less than 30 days before screening, or previous participation in this study.

Known to or suspected of not being able to comply with the study protocol.

Active herpes zoster lesion or dermatitis of any origin at the affected site with PHN.

Evidence of another cause for pain in the area affected by herpes zoster in addition to PHN, such as lumbar radiculopathy, surgery or trauma, if this could confound assessment or self-evaluation of the pain due to post herpetic neuralgia.

Participants who had neurological ablation by block or neurosurgical intervention for control of pain in PHN.

Participants who are undergoing active treatment for cancer, are known to be infected with the human immunodeficiency virus (HIV), or being acutely and intensively immunosuppressed following transplantation.